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NCT05743218
Clinical Efficacy of Acupuncture on the Liver Meridian in Women With Diminished Ovarian Reserve
Conditions: Ovarian Reserve, Acupuncture Therapy, Meridian
Sex: Female
Ages: 18 Years – 40 Years
Phase: NA
Enrollment: 198
Sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Location: China
Summary
Diminished ovarian reserve (DOR) refers to a decrease in the number and quality of oocytes in the ovary, which results in impaired ovarian function and decreased fertility.
Meanwhile, levels of the anti-Müllerian hormone (AMH), antral follicle count (AFC), and Follicle-Stimulating Hormone (FSH) also decrease in patients with DOR.
In general, there is a decline in fertility and premature menopause.
Some patients will have low menstrual volume, oligomenorrhea or even amenorrhea, abnormal uterine bleeding, ovulation disorders, infertility and perimenopausal performance before the age of 40, and eventually develop into premature ovarian failure.
In recent years, with the changes of social culture, living environment, work pressure and other factors, the incidence of this disease has increased year by year, which has a great impact on women's fertility, mental health, quality of life, family relations and other aspects.As a green and safe complementary and alternative therapy, acupuncture has been proved to be effective.
According to the statistics, 904 (33.54%) of the 2695 syndromes indicated by acupoints of the liver meridian recorded in 93 ancient medical books are reproductive disorders, ranking first in the diseases indicated by the liver meridian and the 14 meridians.
The body surface course of the liver meridian is closely related to the genitals, and there is a close relationship between the liver meridian and the genitals in physiology and pathology.
According to the theory of the relationship between meridians and zangfu organs, the study aims to verify the efficacy and safety of acupuncture of the liver meridian and provide high-level research evidence for meridian syndrome differentiation of reproductive system diseases via "treatment from the liver."
Eligibility Criteria
Inclusion Criteria:- The inclusion criteria are as follows:patients with the detection indicators within 3 months before enrollment met the diagnostic criteria of DOR.patients aged between 18 and 40 years old.patients who have received no other treatment in the 2 months before enrollment.
(4) patients who voluntarily participate in this study and can actively cooperate with the study process.(5) patients who have signed an informed consent form.
Patients who meet all five criteria will be eligible for this study.Exclusion Criteria:(1) Patients with polycystic ovarian syndrome, hyperprolactinemia, pituitary or hypothalamic amenorrhea, thyroid dysfunction, congenital malformations, and organic lesions in the reproductive organs.(2) Patients with a history of local ovarian surgery, such as oophorectomy and ovarian tumor surgery.(3) Patients with a history of chemotherapy or pelvic radiotherapy and a history of therapy with immunosuppressive agents.(4) Patients with comorbidities in the cardiovascular system, liver, kidney, hematopoietic system, nervous and mental system, diabetes, hypertension, and other diseases.(5) Patients being administered estrogen, progesterone, or dehydroepiandrosterone (DHEA) within 2 months before enrollment.(6) Patients who cannot tolerate blood or ultrasound testing.
(vii) Patients who are also participating in other clinical trials.(7) Patients who refuse to sign the informed consent form.
Patients who meet any of the above criteria will be excluded.
Source: ClinicalTrials.gov (NCT05743218). StuddyBuddy aggregates publicly available trial information.